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临床试验/NCT04317196
NCT04317196Unknown不适用

Molecular Epidemiology Study of the Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,206 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,206
试验地点
1
主要终点
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery

研究概览

简要总结

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

详细描述

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: Children (1 month -17 years old) and adults (18-80 years old);
  • Sex: All;
  • Those who will receive selective cardiac surgery with cardiopulmonary bypass;
  • Those who signed the informed consent.

排除标准

  • Those with glomerular filtration rate: eGFR<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;
  • Those who have received nephrectomy and kidney transplantation;
  • Those who have suffered from AKI before;
  • Those with incomplete medical history or clinical data.

结局指标

主要结局

Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery

时间窗: 48 hours

The definition of the occurrence of acute kidney injury is according to the acute kidney injury (AKI) definition and staging criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012

次要结局

  • Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery(3 months)
  • Glomerular Filtration Rate(GFR)(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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